Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
Study NCT ID:
NCT05182268
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.
Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.
Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: